Kornimate/medical-research-clean huggingface dataset:
minimally invasive posterior decompression of the cervical spine

Conditions: Cervical Degenerative Disc Disease; Cervical Stenosis; Posterior Spine Surgery

Summary: degenerative stenosis of the cervical spinal canal may be caused by the compression of the posterior part of the dural sac and spinal cord by the hypertrophied ligamentum flavum and facet joints, by the compression of the anterior part of the dural sac and spinal cord by the posterior longitudinal ligament, vertebral osteophytes and protrusion/ herniation. the choice of surgical treatment in such cases is challenging. posterior decompression and fixation is often proposed, but it is associated with a traumatic posterior approach, a large wound, and blood loss, a high risk of surgery site infections, and also instability of the metal fixation is possible. also important is the increase in the surgical procedure cost due to the use of metal implants. an excellent alternative to standard posterior decompression and fixation is a method with isolated decompression of the cervical canal via posterior approach, which does not require any metal fixation.


Eligibility criteria:
inclusion criteria: 1. over 18 years old; 2. degenerative symptomatic cervical stenosis caused by posterior compression (hypertrophied ligament flavum and/or hypertrophied facet joints etc.) confirmed by mri; 3. symptoms persisting for at least 3 months prior to surgery; 4. planned surgical decompression for one and more cervical level; 5. given written informed consent; 6. able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements. exclusion criteria: 1. the need for anterior cervical decompression; 2. prior cervical fusion at any level; 3. any contraindication or inability to undergo baseline and/or follow up mri or x-ray as required per protocol; 4. neck or non-radicular pain of unknown etiology; 5. history or presence of any other major neurological disease or condition that may interfere with the study assessments; 6. previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
efficacy and safety of levalbuterol in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: to investigate the efficacy and safety of repeated dosing of levalbuterol over 6 weeks of treatment in copd.

this study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with copd. approximately 250 subjects will be enrolled to randomize at least 200 subjects. study participation will consist of a total of six study visits over nine weeks for each subject. this study was previously posted by sepracor inc. in october 2009, sepracor inc. was acquired by dainippon sumitomo pharma., and in october 2010, sepracor inc's name was changed to sunovion pharmaceuticals inc.

Eligibility criteria:
inclusion criteria: * male and female subjects must be at least greater than or equal to 35 years of age at the time of consent. * subjects must have a pre-established primary clinical diagnosis of copd. * subjects must have a baseline fev1 less than or equal to 65% * subjects must have a predicted and \>0.70 liter * subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days * subjects must have a fev1/forced vital capacity (fvc) less than or equal to 70% * subjects must have a greater than or equal to 15 pack-year smoking history * subjects must have a baseline medical research council (mrc) dyspnea scale score greater than or equal to 2 * regular use of a prescribed therapy for control of copd symptoms for 3 months prior to study entry. * no copd exacerbations that have required an emergency room visit, hospital admission or intensive out-patient therapy within 1 month prior to study entry exclusion criteria: * females who are pregnant or lactating. * concurrent requirement of oxygen therapy * known history of asthma, or any chronic respiratory disease other than copd (not including chronic bronchitis or emphysema). * diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer. * lung resection of more than one full lobe. * use of intravenous, intra-articular or intramuscular corticosteroids within 30 days of study entry * history of upper or lower respiratory infection within 14 days of study entry. * participation in an investigational drug study within 30 days of study entry.

Keywords: copd chronic bronchitis chronic emphysema
evaluate the neurological effects of erydex on subjects with a-t

Conditions: Ataxia Telangiectasia

Summary: this is an international, multi-center, randomized, prospective, double-blind, placebo-controlled, phase 3 study, designed to assess the effect of erydex (dexamethasone sodium phosphate \[dsp\] in autologous erythrocytes), administered by intravenous (iv) infusion once every 28 days, on neurological symptoms of patients with ataxia telangiectasia (a-t).

the erydex system (eds) is a combination product that is used to load dexamethasone sodium phosphate (dsp) into autologous erythrocytes (erydex) which is infused into the patient. in the placebo arm, the subjects will receive autologous erythrocytes prepared with the eds process using a placebo solution. upon completion of all screening assessments for eligibility, subjects meeting all selection criteria at baseline will be randomized in a 1:1 fashion to erydex or placebo. approximately 86 subjects 6- to 9-years-old, approximately 43 per group, will be randomized. approximately 20 subjects 10 years of age and above, 10 per treatment group, may also be enrolled.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of a-t * in autonomous gait or is helped by periodic use of a support * genetic confirmation of a-t * body weight ≥15 kg exclusion criteria: * participation in another clinical study * immune impairment * history of severe impairment of the immunological system * current neoplastic disease or previous neoplastic disease not in remission for at least 2 years * severe or unstable pulmonary disease * uncontrolled diabetes * current chronic or acute significant renal and/or hepatic impairment * any previous oral or parenteral steroid use within 6 weeks before baseline. treatment with inhaled or intranasal steroids for asthma or allergies, as well as use of topical steroids will be permitted * a disability that may prevent the subject from completing all study requirements

Keywords: ataxia telangiectasia a-t louis-bar syndrome cerebello-oculocutaneous telangiectasia
efficacy of diacerein on ocular surface disease in degenerative arthritis patients

Conditions: Ocular Surface Disease; Osteoarthritis; Diacerein

Summary: dry eyes is multi-factorial disease which inflammation play etiological role. diacerein is drug which has anti-inflammatory effect by antagonist interleukin-1, decrease interleukin-1 receptor, increase interleukin-1 receptor antagonist. this observational study enrolled participants who going to take diacerein for osteoarthritis, measure corneal staining score, ocular surface disease index score, tear osmolarity, tear break up time, schirmer 1 test, interleukin-1 receptor antagonist, interleukin-1 alpha, interleukin-1 beta level in tear at the time of enrollment and after 2 months.


Eligibility criteria:
inclusion criteria: 1. osteoarthritis with 2. ocular surface index score ≥ 13 with 3. corneal staining score ≥ 3 exclusion criteria: 1. allergic to diacerein 2. use cyclosporin within 30 days 3. eyelid problem 4. change artificial tear while in the study 5. pregnancy or breast feeding

Keywords: dry eye syndromes osteoarthritis ocular surface inflammation interleukin-1 interleukin-1 receptor antagonist
virtual reality as a digital premed to alleviate pain and anxiety preoperatively in patients undergoing spine surgery

Conditions: Anxiety and Fear; Pain, Postoperative; Stress

Summary: the aim of this research study is to evaluate the impact of immersive vr exposure on preoperative anxiety and pain. additionally, to assess whether vr intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. investigators hypothesize that the application of pre-operative vr-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.


Eligibility criteria:
inclusion criteria: * adult patients between 25-70 years old, undergoing an elective spinal surgery. * patient's admission prior to surgery day (at least 1 day). * expected hospital stay - 2 days. * capable of providing informed consent and participate in the study follow-up questionnaire. * patients speak polish. exclusion criteria: * congestive heart failure, hypertension and anti-hypertensive medications * adrenal insufficiency * alcohol addiction (evaluated by cage/audit) and substance addiction (evaluated by dudit) * cognitive impairment (evaluated by mmse, moca) * cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (ishihara test), simulator sickness questionnaire * auditory impairment * psychiatric illness (schizophrenia, bipolar disorder, psychotic depression) - (evaluated by mini questionnaire) * patients with neuropathic pain * use of sedative drugs, anti-depressants, anxiolytics, and anti-epileptic drugs * intracranial functional lesions (patients after tbi (traumatic brain injury), cognitive or executive dysfunction) * patient with high risk due to major and emergency operations * claustrophobia * gcs \< 15
a study to evaluate the efficacy and safety of hr19042 capsules in the treatment of autoimmune hepatitis.

Conditions: Autoimmune Hepatitis

Summary: this study will evaluate the efficacy and safety of hr19042 capsules for the treatment of autoimmune hepatitis. it will also explore the optimal frequency and dosage of hr19042 capsules administration for the treatment.


Eligibility criteria:
inclusion criteria: 1. 18 years old≤female or male patients≤70 years old； 2. clinical-confirmed autoimmune hepatitis； 3. biopsy-confirmed autoimmune hepatitis； 4. serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) level ≥ 3 × upper limit of normal (uln)； 5. willing and able to give informed consent and follow the protocols during the trial. exclusion criteria: 1. patients with other chronic liver diseases； 2. patients with liver cirrhosis； 3. patients with hepatic encephalopathy； 4. positive results in hiv-ab/tp-ab/hepatitis virus tests 5. severe chronic or active infection requiring systemic anti-infective therapy within 14 days before screening； 6. patients with severe cardiovascular diseases； 7. patients with malignancy within the past 5 years； 8. patients received organ transplantation； 9. patients treated with any systemic corticosteroids within 3 months before screening； 10. patients treated with any systemic immunosuppressive drugs within the 6 months before screening.
addiction among mental health professionals

Conditions: Addiction

Summary: our goal is to determine the representations of addiction among caregivers working in the field of mental health. we hypothesize that caregivers, despite their investment in care, have a negative social representation of patients suffering from addictive disorders, which could be related to a lack of training on the pathology and its social repercussions.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * health professional with more than 5 years of professional experience in the field of management of mental illnesses * health professional having accepted to participate in the study exclusion criteria: - refusal to participate in the stud

Keywords: addiction mental health
survey of patients with idiopathic orbital inflammation syndrome

Conditions: Orbital Ischemic Syndrome; Orbital Pseudotumor

Summary: the purpose of this study is to characterise the clinical features, histopathology and the treatment outcomes of patients with idiopathic orbital inflammation syndrome.

idiopathic orbital inflammatory syndrome (iois) is a heterogeneous group of disorders characterised by orbital inflammation without any identifiable local or systemic causes. it is a rare clinical entity and a diagnosis of exclusion. lymphomas, thyroid eye diseases or systemic diseases can have similar presentation and so, a histopathological diagnosis is considered important. iois is a difficult condition to treat. compilation of reported small series of patients with iois suggested that they require multiple systemic immunosuppressant drugs and radiotherapy. recently, a large monocentric study including patients with biopsy proven iois showed that up to 40% of them can relapse. their clinical and pathological features did not correlate with treatments outcomes. the investigators decide therefore to conduct a multicentric retro/ prospective study to determine clinical features, histopathology and treatment outcomes of french patients with iois.

Eligibility criteria:
inclusion criteria: * patients with biopsy proven iois or presumed iois * patients with chronic ios * patient with inaugural iois or being treated for iois exclusion criteria: * patients who do not fulfill the inclusion criteria * patients with systemic disease-associated iois * incomplete follow-up of patients treated for iois

Keywords: observational study iois orbital pseudotumor outcome treatment
characterization and quantification of platelet/leukocyte aggregates in patients with suspected heparin-induced thrombocytopenia

Conditions: Heparin-induced Thrombocytopenia; HIT; Platelet Activation; Platelets; Leukocytes; Platelet/Leukocyte Aggregates; HITSTREAM; Flow Cytometry

Summary: the investigators would like to analyze platelet/leukoplak activation, quantify and morphologically characterize these aggregates using in vitro analysis, directly on whole blood from adult patients with suspected hit. this would enable to better describe the in vivo pathophysiology of the hit-suspect patient, and eliminate the need for platelet donors to perform the usual confirmatory techniques, whose inter- and intra-individual variability is very high. what's more, the sra test, evaluated as the reference test, requires the use of radioisotopes and is therefore only carried out in a few biological expertise centers, resulting in a very long delay in the delivery of results. it should also be noted that, in practice, héparine is immediately stopped in patients with suspected hit, and they are put on an expensive anticoagulant (danaparoide sodique or argatroban) in curative doses until the results of the confirmatory tests are back. in this serious, life-threatening condition, it is essential to have a sensitive, specific test to confirm hit as quickly as possible. each patient with suspected hit (rapid \>30% reduction in platelet count after initiation of heparin therapy) should have 4 tubes of 3.2% citrated whole blood (2.7ml) collected at the time of suspected hit (d0) and before any therapeutic switch (or 24 h max after switch). a new sample (4 citrated tubes) will be taken at d4, d7 and d14 during hospitalization, in patients who test positive for anti-pf4/h ac. all patients with suspected hit will follow the standard diagnostic pathway, i.e. a screening test (immunological test for anti-pf4/heparin antibodies, total ig, acl top, werfen) followed by a confirmatory test (platelet aggregation on ta-8v, stago and/or sra). doppler ultrasonography of the lower limbs will be performed in hit-suspect patients with a positive anti-pf4/h antibody test, as currently performed as part of routine care.


Eligibility criteria:
inclusion criteria: * age \> 18 years * any adult patient suspected of having hit, with a positive anti-pf4/h antibody test * patient signed consent to study participation * patient with social security coverage exclusion criteria: * all adult patients with suspected hit and negative anti-pf4/h antibody test. * protected adults (guardianship, under curators) or deprived of liberty

Keywords: heparin-induced thrombocytopenia
benralizumab airway remodeling study in severe eosinophilic asthmatics

Conditions: Asthma

Summary: the purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics. changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ics) plus long acting b2-agonist (laba) with or without additional controller medication. patients who complete treatment will enter 4 weeks follow-up period.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 through 70 years. 2. physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ics plus laba with or without additional controller medication for at least 12 months prior to visit 1, and current treatment with high-dose ics plus laba for at least 3 months prior to visit 1 with or without additional asthma maintenance medication. 3. morning pre-bd fev1 ≥50 to \<80% of predicted normal value (pnv) and ≥1 liter (l) or morning pre-bd fev1 ≥ 50 to \< 90% of pnv, if historical pre-bd fev1 value (within 12 months prior to screening visit) was \< 80% of pnv. 4. a blood eosinophil count meeting any of 3 criteria: ≥300 cells/µl during screening or ≥ 220 to \< 300 cells/μl during screening and documented eosinophil count of ≥ 300 cells/μl in the past 12 months, or ≥150 to \<300 cells/µl during screening plus one of the following: presence of nasal polyps or pre-bd fvc \<65% predicted at visit 2 5. negative pregnancy test. 6. asthma control questionnaire (acq-6) \>1.5. 7. fewer than 12 exacerbations within the 6 months prior to visit 3. exclusion criteria: 1. any disease or concomitant medication which could affect study results or safety of study participants, including: * current smokers * history of cancer * life-threatening asthma * clinically important pulmonary disease other than asthma 2. use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained. 3. previously received: * benralizumab * live attenuated vaccines 30 days prior to the date of randomization. * bronchial thermoplasty in the last 24 months prior to visit 1 * any investigational non-biologic within 30 days (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer. * any marketed or investigational biologic for the treatment of asthma within 4 months (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer. 4. currently pregnant, breastfeeding or lactating women.

Keywords: asthma eosinophilic asthma lung diseases inhaled corticosteroids ics laba benralizumab fasenra mechanism of action remodeling
comparative study of lung bioavailability of hfa-seretide via current spacer devices in healthy volunteers

Conditions: Asthma

Summary: the purpose of this study is to determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (seretide/advair) and whether electrostatic charge within plastic spacers has a clinically relevant impact on the inhaled steroid delivery.

conventional plastic spacers are bulky and can be influenced by electrostatic charge, which can reduce respirable dose delivery especially when used brand new "out of the box". breath actuated integrated vortex spacer (synchro-breathe) is a compact palm sized antistatic device with a vortex chamber which is designed to be more patient friendly and free from the effects of electrostatic charge. the systemic bioavailability from the lung of inhaled fluticasone and salmeterol is dependent on respirable dose delivery, and hence the performance of inhaler devices can be quantified by measuring the degree of adrenal suppression and fall in serum potassium(k) as surrogates for delivered lung dose. this study attempts to compares the systemic bioavailability from the lung in real life conditions for fluticasone/salmeterol combination (measured in terms of relative adrenal suppression and fall in serum k) via the breath actuated synchro-breathe device, pmdi( seretide evohaler), and aerochamber plus \& volumatic spacer used brand new "out of the box" in healthy volunteers.

Eligibility criteria:
inclusion criteria: 1. healthy volunteers 2. male or female 18-65 3. informed consent 4. ability to comply with the requirements of the protocol exclusion criteria: 1. no respiratory disease 2. smokers 3. recent respiratory tract infection (2 months). 4. any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent tia/ cva,that may endanger the health or safety of the participant, or jeopardise the protocol. 5. any significant abnormal laboratory result as deemed by the investigators 6. pregnancy, planned pregnancy or lactation 7. known or suspected contra-indication to any of the imp's 8. concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Keywords: lung bioavailability asthma seretide spacer
consumption of eggs rich in lutein and omega-3 fatty acids on the macular pigment

Conditions: Age-related Macular Degeneration

Summary: this study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin from lucerne protein concentrate and dha from microalgae on the plasma levels of these compounds but also on the macular pigment optical density, whose elevation may be beneficial in the prevention of age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * healthy subjects (male or female), * 18 to 55 years * having signed the consent form, * susceptible to accept the stresses generated by the study, * insured. exclusion criteria: * corrected visual acuity \<8/10th, * history of cardiovascular disease, specifically coronary heart disease, * characterized dyslipidemia \* total cholesterol ³ 2.50 g / l, and / or triglycerides ³ 2.00 g / l * lipid-lowering treatment, * current smoking or person who stopped smoking less than 6 months * cataract or cataract surgery, * diabetes * body mass index (bmi)\> 30 kg/m2, * taking food supplements in the 3 months preceding the start of the study (carotenoids, omega-3 fatty acids, phytosterols), * regular consumption in the three months preceding the start of the study products with added phytosterols. * regular consumption of high fatty fish or shellfish rich in omega-3 (4x a week or more): salmon, sardines, mackerel, herring, trout, tuna, red mullet, sea bass, bream, farmed turbot, mussels, squid / squid, anchovies. * allergy to eggs * dieting * difference significant weight over the last 3 months (\> 3 kg) * inability to understand or adhere to the protocol * persons deprived of liberty * people in a position to judicial protection * pregnant women.

Keywords: eggs optical macular pigment age macular degeneration study for the age macular degeneration prevention